Vedolizumab Dose Escalation Improves Therapeutic Response in a Subset of Patients with Ulcerative Colitis
- PMID: 32710192
- DOI: 10.1007/s10620-020-06486-x
Vedolizumab Dose Escalation Improves Therapeutic Response in a Subset of Patients with Ulcerative Colitis
Abstract
Background: The Gemini trial failed to detect a significant difference in response rate for patients with ulcerative colitis (UC) randomized to standard (every 8 week) vedolizumab dosing vs escalated (every 4 week) dosing. Subsequent real-world data imply the Gemini trial design may have obscured a benefit of escalated dosing.
Aims: We investigated outcomes after vedolizumab dose escalation for patients with UC. We also explored potential clinical predictors of dose escalation requirement.
Methods: In this retrospective study, we included patients with UC who received vedolizumab between 1/2017-1/2019. We compared rates of clinical response (decrease in partial Mayo score by ≥ 2) and remission (partial Mayo < 2) for standard vs escalated dosing.
Results: Among the 90 patients reviewed, 52 achieved and maintained remission on standard dosing. The average time to remission with standard dosing was 33.3 ± 6.6 weeks. After an average of 56.3 ± 7.4 weeks standard dosing, 24 patients (22 "partial responders" and 2 "non-responders") were dose-escalated. Of the 22 "partial responders" dose-escalated, 10 (45%) achieved remission, 10 (45%) achieved further improvement. Neither "non-responder" demonstrated further clinical benefit. Prior anti-tumor necrosis factor (anti-TNF) biologic exposure predicted dose escalation requirement (p = 0.008). Patients requiring dose escalation had more severe disease at baseline as measured by both full Mayo (p = 0.009) and partial Mayo scores (p = 0.01).
Conclusions: We show dose escalation benefited patients with UC who exhibit a "partial response" to standard dosing. Early vedolizumab dose escalation should be considered in both patients with severe disease and those with prior anti-TNF experience.
Keywords: Symptoms; Therapeutic index; Ulcerative colitis; Vedolizumab.
Comment in
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Vedolizumab Dose Escalation: In for a Penny, in for a Pound?Dig Dis Sci. 2021 Jun;66(6):1772-1774. doi: 10.1007/s10620-020-06565-z. Dig Dis Sci. 2021. PMID: 32833157 No abstract available.
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Rescue Therapy with Intensive Vedolizumab Optimization in a Seventeen-Year-Old Girl with Acute Severe Ulcerative Colitis.Dig Dis Sci. 2021 Jul;66(7):2470-2471. doi: 10.1007/s10620-021-06826-5. Epub 2021 Jan 19. Dig Dis Sci. 2021. PMID: 33469810 No abstract available.
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